Leaflet: information for the user

ACOVIL 5 mg tablets

Ramipril

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Acovil contains a medication called ramipril. This belongs to a group of medications called angiotensin-converting enzyme (ACE) inhibitors.

Acovil works as follows:

• Reducing the body's production of substances that could increase blood pressure.
• Relaxing and widening blood vessels.
• Making it easier for the heart to pump blood throughout the body.

Acovil may be used:

• For treating high blood pressure (hypertension).
• To reduce the risk of suffering a heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes).
• To treat the heart when it cannot pump enough blood to the rest of the body (heart failure).
• As treatment after a heart attack (myocardial infarction) complicated by heart failure.

Do not take Acovil

• If you are allergic to ramipril, any other angiotensin-converting enzyme (ACE) inhibitor, or any of the other ingredients in this medication listed in section 6.

The symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of your lips, face, throat, or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, hives, red patches on your hands, feet, and throat, swelling of your throat and tongue, swelling around your eyes and lips, difficulty breathing and swallowing.
• If you have taken or are taking sacubitrilo/valsartán, a medication used to treat a type of chronic heart failure in adults.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Acovil may not be suitable for you.
• If you have renal artery stenosis (narrowing of the renal artery that reduces blood flow to your kidneys).
• During the last 6 months of pregnancy (see section “Pregnancy and breastfeeding”, below).
• If your blood pressure is abnormally low or unstable. Your doctor will need to assess this.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

Do not take Acovil if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking Acovil.

Warnings and precautions

Consult your doctor or pharmacist before taking Acovil:

• If you have heart, liver, or kidney problems.
• If you have lost a lot of minerals or fluids (due to vomiting, diarrhea, excessive sweating, being on a low-sodium diet, taking diuretics for a long time, or being on dialysis).
• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are to receive an anesthetic. This may be given for surgery or any dental work. You may need to stop your treatment a day before; consult your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).
• If you take medications or have any condition that may lower sodium levels in your blood. Your doctor may perform blood tests periodically, particularly to monitor sodium levels in your blood, especially if you are an elderly patient.
• If you are taking medications that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (such as temsirolimus, everolimus, sirolimus) or vildagliptin, NEP inhibitors (such as racecadotrilo) or sacubitrilo/valsartán. For sacubitrilo/valsartán, see section 2 “Do not take Acovil”.
• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• Inform your doctor if you are pregnant (or suspect you may be). Acovil is not recommended during the first 3 months of pregnancy, and may cause serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.

- aliskirén.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as potassium) at regular intervals. See also the information under the heading “Do not take Acovil”.

Children and adolescents

The use of Acovil in children and adolescents under 18 years of age is not recommended because the safety and efficacy of Acovil in children have not been established.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking Acovil.

Use of Acovil with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because Acovil may affect how other medications work. Similarly, some medications may affect how Acovil works.

Inform your doctor if you have taken or are taking any of the following medications, which may make Acovil less effective:

• Medications used to relieve pain and inflammation (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).
• Medications used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as efedrina, noradrenalina, or adrenalina. Your doctor will need to check your blood pressure.

Inform your doctor if you are taking any of the following medications. These may increase the risk of side effects if taken with Acovil:

• Sacubitrilo/valsartán: used to treat a type of chronic heart failure (see section 2 “Do not take Acovil”).
• Medications used to relieve pain and inflammation (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).
• Chemotherapy medications.
• Medications used to prevent organ rejection after a transplant, such as ciclosporina.
• Diuretics, such as furosemida.
• Medications that may increase potassium levels in your blood, such as espironolactona, triamtereno, amilorida, potassium salts, trimetoprim alone or in combination with sulfametoxazol (for infections) and heparina (to make your blood more liquid).
• Glucocorticoids for inflammation, such as prednisolona.
• Alopurinol (used to reduce uric acid in your blood).
• Procainamida (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotrilo (used for diarrhea).
• Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Acovil” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medications. These may be affected by Acovil:

• Medications used to treat diabetes, such as oral medications to lower glucose and insulin. Acovil may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Acovil.
• Lithium (for mental health problems). Acovil may increase your lithium levels in your blood. Your doctor will closely monitor your lithium levels in your blood.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking Acovil.

Taking Acovil with food and alcohol

• Drinking alcohol with Acovil may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking Acovil, speak with your doctor, as medications used to lower blood pressure and alcohol may have additive effects.
• Acovil can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or suspect you may be).

You should not take Acovil during the first 12 weeks of pregnancy and should not take it at all from week 13, as its use during pregnancy may cause harm to your baby. If you become pregnant while taking Acovil, inform your doctor immediately. A suitable alternative treatment should be changed before planning a pregnancy.

Breastfeeding

You should not take Acovil if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

You may feel dizzy while taking Acovil, which is more likely to occur when you start taking Acovil or when you start taking a higher dose of Acovil. If this happens, do not drive or operate tools or machinery.

Acovil contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

How much medication to take

Hypertension treatment

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you should take to control your blood pressure.
• The maximum daily dose is 10 mg once a day.
• If you are already taking diuretics, your doctor may stop or reduce the amount of diuretic you were taking previously before starting treatment with Acovil.

To reduce the risk of suffering a heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the amount you take.
• The usual dose is 10 mg once a day.

Treatment to reduce or delay the worsening of kidney problems

• You can start with a dose of 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 5 mg or 10 mg once a day.

Treatment for heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you are taking.
• The maximum daily dose is 10 mg once a day. It is preferable to administer it twice a day.

Treatment after having had a heart attack

• The usual starting dose is 1.25 mg once a day to 2.5 mg twice a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 10 mg once a day. It is preferable to administer it twice a day.

Older patients

Your doctor will reduce the initial dose and adjust your treatment more slowly.

Taking this medication

• Take this medication orally at the same time every day.
• Swallow the tablets whole with liquid.
• Do not crush or chew the tablets.

If you take more Acovil than you should

Consult your doctor immediately or go to the nearest hospital emergency room. Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the medication packaging with you. This way, your doctor will know what you have taken.

You can also call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Acovil:

• If you forgot to take a dose, take your regular dose when it's time for the next one.
• Do not take a double dose to make up for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Acovil and seek immediate medical attention if you notice any of the following severe side effects, which may require urgent medical treatment:

• Swelling of the face, lips, or throat that may make it difficult to swallow or breathe, as well as itching and hives. This may be a sign of a severe allergic reaction to Acovil.
• Severe skin reactions, including rashes, mouth ulcers, worsening of a pre-existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience:

• Increased heart rate, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems, including heart attack and stroke.
• Difficulty breathing or coughing. These may be signs of lung problems.
• Appearance of bruises with increased ease, bleeding for longer than normal, any sign of bleeding (e.g., from the gums), purple spots on the skin, or catching infections more easily than normal, sore throat, and fever, feeling tired, dizziness, or pale skin. These may be signs of blood or bone marrow problems.
• Severe stomach pain that may radiate to the back. This may be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (urge to vomit), yellow skin or eyes (jaundice). These may be signs of liver problems, such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:

Inform your doctor if any of the following worsen or last longer than a few days.

Frequent(may affect up to 1 in 10 patients)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to occur when starting to take Acovil or when starting a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting quickly.
• Irrespiratory cough, sinusitis, or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling sick.
• Hives on the skin, with or without raised areas.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing higher-than-normal potassium levels in the blood.

Rare(may affect up to 1 in 100 patients)

• Balance problems (dizziness).
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or shivering (paresthesia).
• Loss or changes in the taste of things.
• Difficulty sleeping.
• Feeling sad, anxious, more nervous than normal, or tired.
• Difficulty breathing or worsening of asthma.

• Intestinal angioedema, characterized by abdominal swelling, vomiting, and diarrhea.

• Heartburn, constipation, or dry mouth.
• Urinating more frequently during the day.
• Sweating more than normal.
• Loss or decrease in appetite (anorexia).
• Increased or irregular heartbeats.
• Swelling of arms and legs. This may be a sign that your body is retaining more water than normal.
• Redness.
• Blurred vision.
• Joint pain.
• Fever.
• Sexual dysfunction in men, decreased libido in men or women.
• Increased number of certain white blood cells (eosinophilia) found during a blood test.
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning.

Very rare(may affect up to 1 in 10,000 patients)

• Increased sensitivity to the sun.

Other side effects reported:

Inform your doctor if any of the following worsen or last longer than a few days.

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show very few blood cells.
• Blood tests show lower-than-normal sodium levels.
• Concentrated urine (dark color), feeling unwell or nausea, muscle cramps, confusion, and seizures that may be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Fingers and toes change color when it's cold and feel numb or painful when warmed (Raynaud's phenomenon).
• Enlargement of the chest in men.
• Slowness or difficulty reacting.
• Feeling burned.
• Change in the smell of things.
• Loss of hair.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated. This medication does notrequire special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at thepharmacy's SIGREdrop-off point. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Acovil

The active ingredient is ramipril.

5 mg: Each tablet contains 5 mg of ramipril.

The other components are:

Hypromellose

Pre-gelatinized cornstarch

Microcrystalline cellulose

Sodium stearyl fumarate

Iron oxide red (E 172)

Appearance of the product and contents of the package

Oblong-shaped tablets of 8 x 4 mm, pale red in color, with a notch and marked with 5 and the logo on the upper face and HMP and 5 on the lower face.The tablet can be divided into equal doses.

Acovil 5 mg tablets are presented in blisters of 10, 14, 15, 18, 20, 21, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 320, 500 tablets in aluminum/PVC blisters.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

The marketing authorization holder is:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

The manufacturer responsible is:

Sanofi S.r.l.

Strada Statale 17 km 22

67019 Scoppito (L’Aquila) Italy

Delpharm Dijon

6, Boulevard de L’Europe Quetigny F-21800 France

S.C. ZENTIVA S.A.,

B-dul Theodor Pallady nr. 50, Sector 3, Bucuresti, 032266 – Romania

Sanofi Aventis Deutschland GmbH,

Industriepark Höechst Brüningstraße 50, 65926 Frankfurt am Main, Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Belgium:

Tritace 2.5 mg tablets/tablets/compresses, Tritace 5 mg tablets/tablets/compresses, Tritace 10 mg tablets/tablets/compresses

Bulgaria:

Tritace 5 mg ?????????, Tritace 10 mg ?????????

Cyprus:

Triatec 2.5 mg δισκ?α, Triatec 5 mg δισκ?α

Czech Republic:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Denmark:

Triatec 5 mg tablets

Estonia:

Cardace 2.5 mg tablets, Cardace 5 mg tablets, Cardace 10 mg tablets

Finland:

Cardace 2.5 mg tablets, Cardace 5 mg tablets, Cardace 10 mg tablets

France:

Triatec 1.25 mg tablets, Triatec 2.5 mg tablets, Triatec 5 mg tablets, Triatec 10 mg tablets

Germany:

Delix 2.5 mg tablets, Delix 5 mg tablets, Delix 10 mg tablets

Delix Protect Startset

Delix 1.25 mg tablets, Delix 1.25 mg capsules, Delix 2.5 mg capsules, Delix 5 mg capsules, Delix 10 mg capsules

Greece:

Triatec 2.5 mg δισκ?α, Triatec 5 mg δισκ?α

Hungary:

Tritace Mite 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Ireland:

Tritace 1.25 mg tabs, Tritace 2.5 mg tabs, Tritace 5 mg tabs, Tritace 10 mg tablets

Italy:

Triatec 2.5 mg compresses, Triatec 5 mg compresses, Triatec 10 mg compresses

Latvia:

Cardace 2.5 mg tablets, Cardace 5 mg tablets, Cardace 10 mg tablets

Lithuania:

Cardace 5 mg tablets, Cardace 10 mg tablets

Luxembourg:

Tritace 2.5 mg tablets/tablets/Tabletten, Tritace 5 mg tablets/tablets/Tabletten, Tritace 10 mg tablets/tablets/Tabletten

Norway:

Triatec 2.5 mg tablets, Triatec 5 mg tablets, Triatec 10 mg tablets

Poland:

Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Portugal:

Triatec 1.25 mg capsules, Triatec 2.5 mg capsules, Triatec 5 mg capsules, Triatec 10 mg capsules

Romania:

Tritace 2.5 mg compresses, Tritace 5 mg compresses, Tritace 10 mg compresses

Slovakia:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Slovenia:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Spain:

Acovil 2.5 mg tablets, Acovil 5 mg tablets, Acovil 10 mg tablets

Sweden:

Triatec 2.5 mg tablets, Triatec 5 mg tablets, Triatec 10 mg tablets

United Kingdom:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets, Tritace Titration Pack tablets

Last revision date of this leaflet: June 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.